[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598940":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":21,"studyPopulation":22,"armGroups":23,"interventions":69,"overallOfficials":17,"centralContacts":75,"locations":17,"responsibleParty":81,"collaborators":84,"id":86,"slug":17,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":17,"eligibilityCriteria":91,"healthyVolunteers":92,"sex":93,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":17,"studyType":99,"phases":17,"briefSummary":100,"conditions":101,"keywords":103,"overallStatus":111,"whyStopped":17,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":17},{"fullName":5,"class":6},"Erzurum Regional Training & Research Hospital","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"Correlation between voice features and pain level (VAS score)","Voice parameters such as pitch, tone, speech rate, and pauses will be analyzed and statistically correlated with pain levels as measured by the Visual Analog Scale (VAS).\n\nThe VAS is a self-reported pain measurement tool scored on a scale from 0 to 10, where:\n\n0 indicates no pain, and\n\n10 indicates the worst pain imaginable. Higher scores represent worse pain outcomes.","At the time of enrollment",[14],{"measure":15,"description":16,"timeFrame":12},"Correlation between voice features and functional impairment (Oswestry Disability Index [ODI] or Roland-Morris Disability Questionnaire [RMDQ])","Functional disability levels will be assessed using either the Oswestry Disability Index (ODI) or the Roland-Morris Disability Questionnaire (RMDQ) and will be correlated with acoustic voice features such as pitch, tone, speech rate, and pauses.\n\nThe ODI is scored from 0 to 100, with higher scores indicating greater disability.\n\nThe RMDQ is scored from 0 to 24, where higher scores also indicate greater disability.",null,{"allocation":17,"interventionModel":17,"interventionModelDescription":17,"primaryPurpose":17,"observationalModel":19,"timePerspective":20,"maskingInfo":17},"COHORT","PROSPECTIVE","Chronic low back pain (CLBP) is one of the most common musculoskeletal complaints and a leading cause of disability worldwide. Assessing pain severity and its impact on function is primarily reliant on self-reported tools such as the Visual Analog Scale (VAS) and functional indices like the Oswestry Disability Index (ODI) or Roland-Morris Disability Questionnaire (RMDQ). However, these tools may be influenced by subjectivity and reporting bias. Therefore, objective and non-invasive methods for pain assessment are needed.\n\nThis pilot observational study aims to investigate whether acoustic characteristics of voice recordings can be used to estimate pain intensity and functional impairment in individuals with CLBP. The hypothesis is that pain-induced changes in a patient's psychophysiological state may alter specific voice parameters (e.g., pitch, speech rate, pauses, intonation), which can be quantified through acoustic analysis.\n\nAfter obtaining ethical approval, data will be collected at the Department of Physical Medicine and Rehabilitation. A total of 110 participants aged 18-70 years with chronic low back pain will be recruited. Each participant will be asked to read a standardized one-minute text aloud, and their voice will be recorded in a controlled setting. On the same day, participants will complete the VAS and either the ODI or RMDQ questionnaires.\n\nVoice recordings will be analyzed using speech signal processing tools to extract features such as fundamental frequency, speech rate, articulation rate, pauses, and prosodic variations. These voice parameters will then be statistically correlated with VAS and disability scores.\n\nParticipants will be grouped by their VAS score (0-10), with an equal number of participants targeted for each pain level to ensure balanced data distribution. Written and verbal informed consent will be obtained from all participants. All recordings and data will be anonymized, and participants will retain the right to withdraw from the study at any time without consequence.\n\nThis study adheres to the principles of the Declaration of Helsinki and aims to provide early evidence supporting the feasibility of voice-based pain assessment. If successful, this approach could pave the way for low-cost, scalable, and objective tools to assist in the diagnosis and monitoring of chronic pain conditions.","Adults aged 18 to 70 years with chronic low back pain who are literate and visiting the physical medicine and rehabilitation outpatient clinic. Participants must be able to read and speak Turkish fluently to complete questionnaires and perform the standardized reading task for voice recording. Individuals with acute back pain, neurological disorders, or communication impairments are excluded.",[24,29,33,37,41,45,49,53,57,61,65],{"label":25,"type":17,"description":26,"interventionNames":27},"VAS 0 Group","Participants with chronic low back pain reporting a VAS score of 0",[28],"Other: Voice Recording Procedure",{"label":30,"type":17,"description":31,"interventionNames":32},"VAS 1 Group","Participants with chronic low back pain reporting a VAS score of 1",[28],{"label":34,"type":17,"description":35,"interventionNames":36},"VAS 2 Group","Participants with chronic low back pain reporting a VAS score of 2",[28],{"label":38,"type":17,"description":39,"interventionNames":40},"VAS 3 Group","Participants with chronic low back pain reporting a VAS score of 3",[28],{"label":42,"type":17,"description":43,"interventionNames":44},"VAS 4 Group","Participants with chronic low back pain reporting a VAS score of 4",[28],{"label":46,"type":17,"description":47,"interventionNames":48},"VAS 5 Group","Participants with chronic low back pain reporting a VAS score of 5",[28],{"label":50,"type":17,"description":51,"interventionNames":52},"VAS 6 Group","Participants with chronic low back pain reporting a VAS score of 6",[28],{"label":54,"type":17,"description":55,"interventionNames":56},"VAS 7 Group","Participants with chronic low back pain reporting a VAS score of 7",[28],{"label":58,"type":17,"description":59,"interventionNames":60},"VAS 8 Group","Participants with chronic low back pain reporting a VAS score of 8",[28],{"label":62,"type":17,"description":63,"interventionNames":64},"VAS 9 Group","Participants with chronic low back pain reporting a VAS score of 9",[28],{"label":66,"type":17,"description":67,"interventionNames":68},"VAS 10 Group","Participants with chronic low back pain reporting a VAS score of 10",[28],[70],{"type":71,"name":72,"description":73,"armGroupLabels":74,"otherNames":17},"OTHER","Voice Recording Procedure","Participants will be asked to read a standardized one-minute text aloud in a quiet room. Their voices will be recorded using a high-quality microphone. The recordings will later be analyzed for acoustic features such as pitch, speech rate, pauses, and intonation.\n\nThis procedure is non-invasive and does not involve any clinical or pharmacological intervention.",[25,30,66,34,38,42,46,50,54,58,62],[76],{"name":77,"role":78,"phone":79,"phoneExt":17,"email":80},"nurmuhammet tas","CONTACT","+905323380237","nu_mu_ta@hotmail.com",{"type":82,"investigatorFullName":77,"investigatorTitle":83,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"SPONSOR_INVESTIGATOR","Principal Investigator",[85],{"name":5,"class":6},"100598940",false,"NCT07078019","Predicting Pain and Disability From Voice Recordings in Low Back Pain","Estimation of Pain Level in Patients With Chronic Low Back Pain From Voice Recordings: A Comparative Pilot Study With VAS and Lumbar Function Index","Inclusion Criteria:\n\n* Age between 18-70 years\n* Diagnosed with chronic low back pain and attending the physical medicine and rehabilitation clinic\n* Literate (able to read and write)\n\nExclusion Criteria:\n\n* Age below 18\n* Illiterate individuals",true,"ALL","18 Years","70 Years",{"count":97,"type":98},110,"ESTIMATED","OBSERVATIONAL","This study aims to investigate whether pain intensity (assessed by Visual Analog Scale - VAS) and functional impairment (Roland-Morris Disability Questionnaire \\[RMDQ\\] or Oswestry Disability Index \\[ODI\\]) in patients with chronic low back pain can be estimated using acoustic features extracted from short voice recordings.",[102],"Chronic Low Back Pain (CLBP)",[104,105,106,107,108,109,110],"Chronic low back pain","Voice analysis","Oswestry Disability Index","Roland-Morris Questionnaire","Acoustic biomarkers","Pain assessment","VAS","NOT_YET_RECRUITING","2025-09-18",{"date":114,"type":115},"2025-09-19","ACTUAL",{"date":117,"type":98},"2025-09-28",{"date":119,"type":98},"2025-09-30",{"name":77,"class":6}]